Elizabeth Holmes, the beleaguered founder-and-chief of Theranos, has agreed to publish scientific data that will supposedly affirm the accuracy and reliability of its blood tests. But as a recent FDA inspection report points out, things don’t look good.

Theranos, the makers of an innovative needle-free blood test, has been under intense scrutiny since the recent publication of a damning Wall Street Journal article alleging that the company has been using outside diagnostic equipment to conduct its own blood tests. It was also suggested that the company’s custom-built Edison machines have been producing different results than those generated by conventional diagnostic tools.

Advertisement

In defense, Theranos published a lengthy rebuttal last week dismissing the allegations and affirming its offering, though no actual data was presented to quell concerns. Now, under intense pressure to do so, Theranos CEO Elizabeth Holmes has agreed to publish the data.

As reported in the New York Times, Holmes made the announcement at a conference on Monday night sponsored by the Cleveland Clinic. She said that presenting the data would be more effective than trying to counter “unfair” articles in the media, adding that: “Data is a powerful thing because it speaks for itself.”

This represents a dramatic about-face for the company, which has been incredibly secretive about its proprietary blood test, which can accommodate numerous tests from a few drops of blood extracted by a simple finger-stick, rather than a needle in the arm.

“We were never against that,” said Holmes at the conference. “I just always believed that as the FDA decision summaries came out one by one with our data, that actually that would be so much more transparent a model.”

The details of the data will be of great interest to a number of stakeholders, including drugstore chain Walgreens—which features “wellness centers” equipped with Theranos’s technology—and drug giants Pfizer and GlaxoSmithKline.

Advertisement

But if recent inspection reports published by the FDA are of any indication, the Theranos story could start to get a lot worse. As reported in Vox earlier today (and now elsewhere), the FDA is taking issue with the fact that Theranos used an unapproved medical device, did not sufficiently follow up on customer complaints, and had problems with its lab and quality assurance protocols. The unapproved medical device is the company’s “nanotainer,” a small collection tube.

(Credit: FDA via Vox)

The heavily redacted reports, which were posted in response to a Freedom of Information Act request, can be found here and here.

Advertisement

Update: Theranos has released a statement to explain the recent FDA findings. Here it is in full:

In response to our voluntary outreach to the FDA in the fall of 2013, FDA provided guidance that they wanted to regulate our Nanotainer tubes and review our proprietary systems, and we submitted them for clearance.

We then worked closely with FDA, culminating in our first FDA clearance for HSV-1 in July, which included clearance of the associated proprietary Theranos devices, software and Nanotainer tubes. Our first FDA inspection began on August 25, 2015, as we have previously discussed.

This inspection focused on Theranos’ FDA quality systems compliance, toward which we had been working in anticipation of upcoming clearances. As a company, we had already been transitioning from the CLIA laboratory quality systems under which we had been working, in compliance with our understanding of current FDA policy.

We worked closely with FDA representatives and provided detailed information. At the conclusion of the inspection, FDA issued two Form 483s outlining observations made during the inspection. None of these observations pertain to Theranos’ analytical devices or chemistries, or the manufacturing infrastructure for either. The observations were specific to only one of Theranos’ nanotainer tubes. All observations were specific to the nanotainers operating under the CLIA lab quality framework. The correction to the observations was to cut over to the FDA Quality Systems framework.

We believe that we addressed and corrected all the observations at the time of, or within a week of, the inspection and have submitted documents to FDA that say so, including extensive documentation, as well as outlining our path to the whole QSR transition going forward. Their observations are, by their very nature, preliminary and as this is a time of evolving policy, we have advocated for the transition from the LDT framework to the FDA quality systems framework.

We voluntarily decided to cut all our operations over in real-time to the QSR systems we’d already built over the past year in all areas, including prior to certain clearances, despite the evolving policy in this space. We are charting new pathways, and are working to create a model for the transition from the LDT framework to the FDA quality systems framework. In our discussions with FDA, we determined that in order to do so, it was appropriate to temporarily pause use of the Nanotainer™ tubes, that are currently waiting for clearance, for all tests except our cleared HSV-1 test as we cut over to FDA quality systems. We believe this is the right action to take as we wait for clearance of the Nanotainer™ tubes, for which we have submitted all our data to the agency, so that we can be compliant with operating under the FDA quality systems framework in and of itself. We are in close contact with FDA in this process.

Over 120 of the tests developed for use on our devices used as part of Theranos proprietary technologies have been submitted in pre-submissions to FDA. This voluntary engagement with FDA is not only a statement about our confidence in our technologies, but this summer’s clearance and CLIA waiver would not be possible if our devices and technologies did not work with those tests. Theranos’ technologies includes its devices, chemistries, consumables, and software, in addition to its Nanotainer tubes. These proprietary systems and technologies – which we protect as intellectual property – have been rigorously tested and reviewed, and continue to be rigorously tested and reviewed.